Understanding and Reducing Variation in Outcomes of Cleft Lip and Palate Surgery

了解并减少唇裂和腭裂手术结果的变化

• 批准号: 9476136
• 负责人: Thomas James Sitzman
• 金额: $ 10.1万
• 依托单位: PHOENIX CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-03 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9476136
• 关键词: Address; Adoption; Affect; Age; Antibiotics; Appearance; Attitude; Award; Biometry; Cardiovascular Surgical Procedures; Caring; Characteristics; Child; Child Care; Child health care; Clinical; Clinical Data; Clinical Investigator; Clinical Management; Clinical Research; Clinical Trials; Communities; Controlled Clinical Trials; Craniofacial Abnormalities; Data; Data Analyses; Data Set; Databases; Dental; Development; Disease; Effectiveness; Elements; Environment; Esthetics; Evaluation; Face; Fostering; Funding; Future; Goals; Grant; Growth; Health; Health Services Research; Hospitals; Incidence; Individual; Inequality; Institution; International; Intervention; Intervention Studies; Investments; Judgment; K-Series Research Career Programs; Knowledge; Learning; Left; Link; Low Prevalence; Master of Public Health; Measurement; Measures; Medical; Medical center; Medicine; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Monitor; Nature; Operative Surgical Procedures; Outcome; Outcome Measure; Outcomes Research; Palate; Patient-Focused Outcomes; Patients; Pediatric Hospitals; Pilot Projects; Plastic Surgeon; Positioning Attribute; Postoperative Period; Predictive Factor; Preparation; Procedures; Protocols documentation; Provider; Public Health; Reading; Research; Research Activity; Research Personnel; Research Training; Resources; Severities; Speech; Speech Disorders; Speed; Standardization; Structure; Surgeon; System; Testing; Time; Training; Training Activity; Training Support; Treatment Protocols; Treatment outcome; Universities; Variant; administrative database; base; care burden; care delivery; care systems; career; career development; cleft lip and palate; clinical practice; college; compare effectiveness; contextual factors; cost; craniofacial; design; dissemination research; effective therapy; experience; experimental study; hands-on learning; health care delivery; implementation research; implementation science; improved; improved outcome; medical specialties; meetings; mortality; multidisciplinary; patient oriented research; post intervention; preference; primary outcome; programs; prospective; public health relevance; repaired; research data dissemination; research study; skills; success; therapy design; tool; treatment center

DESCRIPTION (provided by applicant): The scientific basis for management of cleft lip and palate is weak at best. Almost no elements of care have been evaluated with adequately powered, well-controlled clinical trials. Without high-quality evidence, providers have relied on individual judgments and preferences. The result is a broad variation in both the care children receive and the outcomes they achieve. There is a critical need to establish the efficacy of existing treatments and to speed dissemination and implementation of research findings into practice. To address this unmet need, Thomas Sitzman, a plastic surgeon with clinical expertise in the care of children with cleft lip and palate, is submitting this application for a K3 Mentored Patient-Oriented Research Career Development award. Dr. Sitzman is ideally suited at this stage in his career to benefit from a K23 award, which will build on his extensive clinical training as a cleft surgeon, his prior research studying variation in care delivery, and his ongoin coursework toward a Master of Public Health degree. Through the research and training activities proposed in the application, he will acquire the tools necessary to achieve his long-term goal of becoming an independent investigator evaluating existing treatments and designing healthcare delivery interventions to reduce provider-based variation and speed implementation of effective treatments. The candidate will achieve five specific learning objectives during this award, each targeted at specific needs for his long-term career goal. He will develop expertise in secondary data analysis, enabling him to overcome the low prevalence of craniofacial anomalies at individual centers by using large national datasets. He will acquire advanced skills in longitudinal data analysis, enabling him to address the time-dependent nature of outcomes in cleft surgery. He will learn to apply implementation science in the design of healthcare delivery interventions, enabling him to accelerate implementation and dissemination of research findings. He will gain expertise in the design and management of clinical trials so that he can evaluate efficacy of individual treatments. Finally, Dr. Sitzman will strengthen his academic and professional skills, including grant preparation, presentation of scientific findings, and establishing a network of collaborators across institutions. These learning objectives will be achieved through coursework, directed readings, and hands-on learning. Dr. Sitzman will receive mentorship throughout the award from established investigators deeply invested in his success. He and his primary mentor, Maria Britto, MD, MPH, have assembled a strong team of co-mentors to guide Dr. Sitzman through the proposed training and research activities. This team includes two internationally recognized experts in cleft lip and palate clinical research, along with experts in biostatistics, implementation science and clinical trials. His mentors will provide training, critically evaluate his research, monitor his progress toward independence, and identify specific opportunities for further development. The proposed training activities and research will be enhanced by the institutional environment at Cincinnati Children's Hospital Medical Center (CCHMC) and the University Of Cincinnati College Of Medicine. This environment provides direct mentorship from senior investigators conducting descriptive, interventional, and implementation research; structured seminars to support training and foster exchange of ideas; and access to resources within the University of Cincinnati CTSA program. CCHMC has made a sustained investment to the candidate to support his past and ongoing career development, including protected time and start-up funds over the past three years that enabled him to build the multi-disciplinary mentoring team and conduct preliminary studies to conceptualize the proposed research. The research proposed in this application will test the central hypothesis that modifiable factors from the surgeon and treatment center, including both individual components of the treatment protocol and the system of care delivery, contribute to the outcomes of cleft surgery. This hypothesis will be tested through three specific aims: (1) Determine surgeon and treatment center factors associated with outcomes of primary surgery; (2) Compare the effectiveness of standardized treatment and outcome measurement to a historical control where care was delivered based on individual judgments by the surgeon and treatment center; and (3) Develop and pilot an implementation strategy for standardized measurement of cleft outcomes. Specific Aims 1 and 2 will be achieved by applying longitudinal data analysis to existing national databases. Specific Aim 3 will be achieved using implementation science. The results of this research will improve the health of children with cleft lip and palate in two ways: by identifying modifiable factors associated with their treatment outcomes, which will be evaluated in future prospective experimental studies; and by developing an implementation strategy for standardized outcome measurement that enables surgeons and treatment centers to critically evaluate outcomes, compare their results with those from other centers, and focus their improvement activities. Dr. Sitzman's clinical expertise and previous research training, his team of experienced mentors invested in his success, and his extensive institutional support make him ideally positioned to benefit from a K23 Career Development Award at this stage in his career. Through the proposed research and training activities, he will develop into an independent investigator with the tools and experience to evaluate the efficacy of existing treatments in cleft surgery and to accelerate implementation of research findings into clinical practice.

描述（由申请人提供）：管理唇腭裂的科学基础充其量是薄弱的。几乎没有任何护理要素得到充分把握度、对照良好的临床试验的评价。没有高质量的证据，提供者依赖于个人的判断和偏好。其结果是，儿童得到的照顾和他们取得的成果存在很大差异。迫切需要确定现有治疗方法的疗效，并加快传播研究成果并将其付诸实践。 为了解决这一未满足的需求，托马斯西茨曼，整形外科医生与唇腭裂儿童护理的临床专业知识，是提交此申请的K3指导以患者为导向的研究职业发展奖。Sitzman博士非常适合在他的职业生涯的这个阶段受益于K23奖，这将建立在他广泛的临床 作为一名唇腭裂外科医生的培训，他以前的研究，研究护理提供的变化，以及他正在进行的公共卫生硕士学位课程。通过申请中提出的研究和培训活动，他将获得必要的工具，以实现他的长期目标，即成为一名独立的研究者，评估现有的治疗方法，并设计医疗保健服务干预措施，以减少基于提供者的变化，并加快有效治疗的实施。 候选人将在此期间实现五个具体的学习目标，每个目标都针对其长期职业目标的特定需求。他将发展在二级数据分析的专业知识，使他能够克服颅面异常的低患病率在个别中心通过使用大型国家数据集。他将获得纵向数据分析的高级技能，使他能够解决唇腭裂手术结果的时间依赖性。他将学习在医疗保健服务干预措施的设计中应用实施科学，使他能够加快研究成果的实施和传播。他将获得临床试验设计和管理方面的专业知识，以便他能够评估个体治疗的疗效。西茨曼将加强他的学术和专业技能，包括拨款准备，科学发现的介绍，并建立跨机构的合作者网络。这些学习目标将通过课程作业，定向阅读和动手学习来实现。 Sitzman博士将在整个奖项期间接受对他的成功进行深入投资的知名调查人员的指导。他和他的主要导师，玛丽亚布里托，医学博士，公共卫生硕士，已经组建了一个强大的共同导师团队，以指导博士西茨曼通过拟议的培训和研究活动。该团队包括两名国际公认的唇腭裂临床研究专家，沿着还有生物统计学、实施科学和临床试验专家。他的导师将提供培训，批判性地评估他的研究，监测他走向独立的进展，并确定进一步发展的具体机会。 拟议的培训活动和研究将通过辛辛那提儿童医院医疗中心（CCHMC）和辛辛那提大学医学院的机构环境得到加强。这种环境提供了从高级研究人员进行描述性，干预性和实施研究的直接指导;结构化的研讨会，以支持培训和促进思想交流;并获得辛辛那提CTSA计划内的大学资源。CCHMC对候选人进行了持续的投资，以支持他过去和正在进行的职业发展，包括在过去三年中保护的时间和启动资金，使他能够建立多学科指导团队并进行初步研究，以概念化拟议的研究。 本申请中提出的研究将测试中心假设，即来自外科医生和治疗中心的可修改因素，包括治疗方案的各个组成部分和护理提供系统，有助于唇腭裂手术的结果。将通过三个具体目标来检验这一假设：（1）确定与初次手术结局相关的外科医生和治疗中心因素;（2）将标准化治疗和结局测量的有效性与历史对照进行比较，其中根据外科医生和治疗中心的个人判断提供护理;（3）制定并试行唇腭裂治疗结果标准化测量的实施策略。具体目标1和2将通过对现有国家数据库进行纵向数据分析来实现。具体目标3将通过实施科学来实现。本研究结果将有助于改善唇腭裂儿童的健康状况 唇腭裂的治疗方法有两种：一是确定与其治疗结果相关的可修改因素，这将在未来的前瞻性实验研究中进行评估;二是制定标准化结果测量的实施策略，使外科医生和治疗中心能够严格评估结果，将他们的结果与其他中心的结果进行比较，并集中精力进行改进。 Sitzman的临床专业知识和以前的研究培训，他的经验丰富的导师团队投资于他的成功，以及他广泛的机构支持，使他处于理想的位置，从K23职业发展奖在他的职业生涯的这个阶段受益。通过拟议的研究和培训活动，他将发展成为一名独立的研究者，拥有评估现有唇腭裂手术治疗效果的工具和经验，并加速将研究成果应用于临床实践。